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Details for New Drug Application (NDA): 017808

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NDA 017808 describes MIACALCIN, which is a drug marketed by Mylan Ireland Ltd and is included in two NDAs. It is available from four suppliers. Additional details are available on the MIACALCIN profile page.

The generic ingredient in MIACALCIN is calcitonin salmon. There are fourteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the calcitonin salmon profile page.

Summary for NDA: 017808

Mylan Ireland Ltd
calcitonin salmon

Pharmacology for NDA: 017808


Suppliers and Packaging for NDA: 017808

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
calcitonin salmon
INJECTABLE;INJECTION 017808 NDA Novartis Pharmaceuticals Corporation 0078-0149 0078-0149-23 2 mL in 1 VIAL (0078-0149-23)
calcitonin salmon
INJECTABLE;INJECTION 017808 NDA Sebela Pharmaceuticals Inc. 54766-149 54766-149-23 2 mL in 1 VIAL, MULTI-DOSE (54766-149-23)

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength100 IU/ML
Approval Date:Jul 3, 1986TE:RLD:No

Summary for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength200 IU/ML
Approval Date:Mar 29, 1991TE:RLD:Yes

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